Fracture of Shaft of Tibia Clinical Trial
— FRSmartFixOfficial title:
Clinical Data Collection With a Novel Biofeedback Technology for Continuous Monitoring of Bone Healing
| NCT number | NCT02094209 |
| Other study ID # | FRSmartFix |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2015 |
| Est. completion date | July 2017 |
| Verified date | January 2018 |
| Source | AO Innovation Translation Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
20 patients having received an AO large external fixator at the tibia will be equipped with a data logger device (AO Fracture Monitor) attached post-operation to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to weight bearing for up to 6 months by means of a strain gauge. Several parameters are calculated from the recorded change in the strain signal and are stored at a regular interval.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | July 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age 18 years and older - Diagnosis of Femoral or tibial fracture (AO 41-43) - External fracture fixation with AO large external fixator - Capable of at least partial weight-bearing - Informed consent obtained, i.e.: - Ability to understand the content of the patient information/Informed Consent Form (ICF) - Willingness and ability to participate in the Focused Registry according to the Registry Plan (RP) - Signed and dated Ethics Committee (EC) approved written informed consent Exclusion Criteria: Preoperative exclusion criteria: - External fixation as temporary stabilization - Joint-bridging external fixation - Any not medically managed severe systemic disease - Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment - Pregnancy or nursing mother - Emergency patient - Prisoner - Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Berufsgenossenschaftliche Unfallklinik | Tübingen | Baden Württemberg |
| Lead Sponsor | Collaborator |
|---|---|
| AO Clinical Investigation and Publishing Documentation |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in Parameters derived from the AO Fracture Monitor during bone healing | AO Fracture Monitor: Mean deformation amplitude per 6 hours Mean deformation rate Number of load-cycles Histogram of patient activity (load intensity distribution) |
Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months | |
| Secondary | Change in Pain during bone healing | Pain measured with visual analog scale (VAS) | Preoperative, Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery) | |
| Secondary | Change in weight-bearing during bone healing | Documentation of allowed weight-bearing | Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery) | |
| Secondary | Repeated reference deformation at a load of 20 / 30 kg | Two reference deformation values are measured under a load 20 kg and 30 kg respectively. The patient steps with his injured leg on a bathroom scale and loads it first with the reference load of 20 kg. The investigator then starts the measurement of the corresponding deformation value. After an acoustic signal indicates the end of the measurement, the procedure is repeated with a reference load of 30 kg. If the patient is not able to put the required load on his leg (e.g. due to pain), the reference value should be measured at a lower load with a note of the actually applied load in the patient record. | Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery) | |
| Secondary | Patient information | Patient demographics Comorbidities |
Up to 4 weeks before surgery | |
| Secondary | Treatment information | Fracture classification according to AO and Gustilo Reason for external fixator treatment Previous treatment related to current injury, if any Fixator configuration |
Discharge | |
| Secondary | Development of the radiological healing assessment: RUST system | The Radiographic Union Score for Tibial fractures (RUST score) is a reliable score to assess the healing of tibial fractures. Each of the four cortices (anterior, posterior, medial and lateral) is given a value from 1 to 3, depending on the presence of a callus and the visibility of the fracture line. The sum of the individual cortical scores results in a RUST value between 4 (definitely not healed) to 12 (definitely healed). To investigate, whether patient activity as measured by the AO Fracture Monitor correlate with the radiological assessed course of healing. |
Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery) |